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Re: Riley4 post# 680890

Sunday, 03/24/2024 1:02:50 PM

Sunday, March 24, 2024 1:02:50 PM

Post# of 687744
If it had “”known positive results” they wouldn’t have changed the endpoints and they would have submitted a BLA to the FDA 3 years ago. Instead they submit the garbage they did to the MHRA with an unmatched ECA because the FDA is explicit about defining the ECA prior to running the trial. The MHRA will reject it for the same reason even though they don’t have that requirement in writing. It’s all to buy time and kick the can down the road while Advent builds its business so LP can sell it while laughing to the bank.
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